Aurobindo Pharma Gets USFDA Nod for Generic Epilepsy Drug Perampanel
Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market generic Perampanel tablets in multiple strengths, the pharmaceutical company said in a regulatory filing.
Perampanel is used to treat partial-onset seizures, with or without secondarily generalised seizures, in epilepsy patients aged four years and above. It is also approved as an adjunctive treatment for primary generalised tonic-clonic seizures in epilepsy patients aged 12 years and older.
According to the company, the approved product is bioequivalent and therapeutically equivalent to Fycompa Tablets, the reference listed drug marketed by Catalyst Pharmaceuticals Inc.
The generic medicine will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of Aurobindo Pharma. The company plans to launch the product in the third quarter of FY27.
Data from IQVIA's MAT for the 12 months ended August 2026 estimates the US market size for the approved product at around $67 million.
With this approval, Aurobindo Pharma's total number of ANDA approvals from the USFDA has risen to 599, comprising 574 final approvals and 25 tentative approvals.
Perampanel tablets are indicated for the treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged four years and older. The drug is also indicated as adjunctive therapy for primary generalised tonic-clonic seizures in patients aged 12 years and older. ALSO READ: Repo Rate Hike Coming? Majority of Economists Expect 25-Bps Hike in RBI October Policy
